Are the protests of insomniacs who rely on Ambien reasonable considering the new evidence for the potential risks of a higher Ambien dosage?
To answer this question, some background to the issue is needed.
The new ambien dosage
This week, the United States Food and Drug Administration (FDA) announced that the manufacturers of the sleeping pill Ambien, and other sleeping pillls containing Zolpidem, would have to reduce the dosage.
The standard recommended Ambien dosage for women was reduced from 10mg to 5mg. And for extended release formulations, the dosage was reduced from 12.5mg to 6.25mg.
The FDA also decided that for men the dosage would be better if lowered, though isn’t an actual requirement.
In addition to the dosage being lowered, the FDA further adds that medical practitioners should advise patients taking sleeping pills containing Zolpidem that they are at a higher risk of impaired mental alertness.
Clinical trials showing worse driving skills
The reason is that clinical trials and driving simulation studies have apparently shown that women perform some tasks, such as driving, less well the morning after taking Ambien.
They found that women eliminate Zolpidem slower than men, though men also have a small chance of driving worse the next morning.
This was widely reported in the news, but what’s particularly interesting to me is the reaction from many people who rely on such sleeping pills to manage their insomnia.
The comments sections of online news articles show a strong reaction from people who believe that they tolerate their higher Ambien dosage very well. Many people feel they pose no potential threat to others from activities such as driving.
Unsurprisingly, the manufacturers of Ambien, Sanofi, also released a statement saying that they believe Ambien to be safe according to their clinical data and 20 years of use by millions of people.
Ambien has indeed had a great deal of testing by people – it’s the most popular sleeping pill available in many countries. And in 2011 in the United States, 44.8 million prescriptions were written for sleeping pills containing Zolpidem.
With so much apparently safe usage of the higher Ambien dosage and other Zolpidem containing sleeping pills, how bad could the results of these simulation studies have been?
Too much Ambien still in the bloodstream the next morning
The FDA reports that recent driving simulation studies found that if people have over 50 ng/mL Zolpidem in the blood, then there’s an increased risk of having a driving accident.
The simulation studies involved 250 men and 250 women taking a dose of 10mg Ambien.
8 hours after dosage, they discovered that 15% of women and 3% of men exceeded the levels of 50 ng/mL, with 4 people having more than 90 ng/mL.
The results of the group taking the extended-release 12.5mg show even higher incidents of elevated Zolpidem amounts in the blood: 33% of women and 25% of men.
Assuming there are many people taking the higher Ambien dosage just before going to bed, as advised to do so, and then driving the next morning, the studies do appear to give cause for concern.
What the manufacturer of Ambien says
This issue isn’t new news, with the following statement appearing on Sanofi’s website:
Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported with sedative-hypnotics, including zolpidem
They then go on to say:
Due to the risk to the patient and the community, discontinuation of Ambien CR should be strongly considered for patients who report a “sleep-driving” episode.
So should people be given a chance to use the old Ambien dosage, and hope that if they are one of the few people (and admittedly, research does suggest that thankfully sleep-driving is very rare) then they will be responsible to themselves and others and discontinue the drug?
Or should anything that carries such a potentially life threatening risk be seriously addressed?
Well, perhaps the answer can be found in another statement on Sanofi’s website:
As with “sleep-driving”, patients usually do not remember these events.
So if patients don’t always remember that they were sleep-driving, how can they be expected to report the episode and therefore discontinue the drug?
Why insomniacs feel it’s unfair
When reading the many angry comments left on news websites by insomniacs who had the higher Ambien dosage, 5 main points come across:
1. That they feel they shouldn’t be punished because the drug can have dangerous effects on a minority of people.
2. That the dosage should be tailored to each individual’s needs.
3. That they believe some people don’t follow the guidance properly (taking the sleeping pill at the wrong time, or mixing it with alcohol) and this is why dangerous behavior can occur.
4. That if they don’t get a good night’s sleep, they are even more at risk of having a driving accident.
5. Some people don’t drive anyway, so why should they suffer because of those that do?
While it’s understandable that people who feel Ambien has transformed their lives after suffering from insomnia, the risks have to be balanced.
Although the FDA states that only a few dozen incidents of sleep-driving involving Ambien have been reported, they suspect there have been many more unreported cases. And many of these cases could well have been catastrophic in their consequences.
Should the reduction in the dosage of Ambien have been allowed?
Sleeping pills aren’t meant to be a long-term solution, as I discussed in a previous article. If the research in that article is true, and many people have been using sleeping pills like Ambien for an excessively long time, then perhaps the lowering of the dose might have a positive long-term effect, even if it’s difficult for people in the short term.
The FDA’s research does appear to be quite conclusive. Even without misusing the sleeping pills, many people are at a higher risk of an accident after taking the previously recommended Ambien dosage, and therefore the community is also at risk.
In an ideal world, it would of course be better if patients can have a tailored approach. I can completely understand why, for example, that people who don’t drive or operate dangerous machinery would be so annoyed by this.
I also understand that there are so many factors involved in how safely someone drives, that it’s perhaps unfair to group everyone in one pot.
I guess another problem, and perhaps one the FDA themselves won’t want to admit, is that it’s not just the patients that have to act responsibly, but also the doctors. Do they trust all doctors to prescribe carefully, and not give in to patients’ demands for a higher dose even if they think that patient is a higher risk?
And do doctors have the time or resources to carefully evaluate exactly what the ideal dose would be from one person to the next?
Maybe at the end of the day the FDA decided that a blanket ban on higher doses would be the simplest and easiest way to eliminate the risk. Even if that means that some people – especially women – who don’t present a risk, feel that their sleep is going to suffer as a result.